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Esomeprazole evaluation in proton pump inhibitor non-responsive non-erosive gastroesophageal reflux disease
2011-005203-32Phase 4
Key facts
- Status
- Active
- Start
- Dec 2011
- Countries
- 1
- Sponsor
- Università Campus Bio-Medico di Roma
- Modality
- Small Molecules
- Drugs
- esomeprazole
- Conditions
- Non-erosive Gastroesophageal Reflux Disease (NERD)
01
Overview
Phase 4, open-label, single-arm trial of esomeprazole in Non-erosive Gastroesophageal Reflux Disease (NERD), sponsored by Università Campus Bio-Medico di Roma. Primary endpoint: Prevalence of resistant or poorly responsive NERD after standardized esomeprazole treatment. Started Dec 2011; status: active.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Esomeprazole 8-week single group
Single open-label treatment group receiving esomeprazole 40 mg daily.
03
Who it enrols
Adults aged 18 to 70 years with non-erosive gastroesophageal reflux disease and inadequate response to proton pump inhibitor therapy; excludes patients with prior erosive esophagitis or Barrett's esophagus.
04
Endpoints
Primary
Prevalence of resistant or poorly responsive NERD after standardized esomeprazole treatment
Secondary
Prevalence of functional heartburn among proton pump inhibitor non-responders
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